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U.S. Department of Health and Human Services

Class 2 Device Recall Xper Flex Cardio

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  Class 2 Device Recall Xper Flex Cardio see related information
Date Initiated by Firm November 20, 2017
Create Date June 07, 2018
Recall Status1 Open3, Classified
Recall Number Z-2115-2018
Recall Event ID 80057
510(K)Number K101571  
Product Classification Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
Product Xper Flex Cardio Physiomonitoring System

The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves.
Code Information MODEL #(s):  453564428541 (Service # 453564241911), 453564243601 (Service # 453564483331), 453564634211 (Service # 453564621801) SERIAL NUMBERS: US1203010251, US1239000027, US1203010279, US1203010280, US1203010308, US1203010334, US1203010346, US1203010352, US1203010358, US1203010360, US1203010366, US1203010375,  US1203010398, US1203010407, US1304000043, US1304000046,  US1224000050, US1550001470, US1251000063, US1109010070,  US1109010072, US1109010075, US1201010130, US1331000013, US1505000507, US1343000034, US1311000042, US1337000033, US1201010112, US1201010119, US1201010120, US1201010122, US1202010171, US1202010186, US1202010202, US1203010396,  US1231000007, US1231000032, US1231000050, US1231000074, US1231000090, US1234000008, US1311000016, US1311000023, US1248000071, US1708000101, US1720000441, US1550001478,  US1248000065, US1729000603, US1352000006, US1352000022, US1352000044, US1352000046, US1352000048, US1107010005,  US1231000060, US1537001268, US1537001272, US1537001276, US1537001277, US1537001280, US1537001338, US1202010174,  US1417000023, US1419000042, US1412000038, US1419000004,  US1419000023, US1419000052, US1424000010, US1424000018, US1431000027, US1239000034, US1550001491, US1338000001,  US1550001502, US1550001468, US1611001807, US1611001814,  US1611001826, US1611001831, US1611001850, US1248000004,  US1248000025, US1248000028, US1248000035, US1517000665,  US1517000671, US1517000680, US1443000225, US1724000551,  US1724000561, US1729000573, US1729000601, US1729000604,  US1311000065, US1407000058, US1334000037, US1224000027,  US1304000017, US1517000691, US1517000696, US1352000036, US1652000003, US1652000011, US1652000016, US1652000042, US1505000498, US1505000518, US1505000567, US1337000007, US1337000008, US1343000057, US1352000052, US1203010408,  US1511000639, US1534001157, US1534001158, US1534001163, US1534001165, US1534001167, US1534001171, US1534001220,  US1534001223, US1534001226, US1534001229, US1534001230,  US1534001232, US1534001233, US1534001237, US1537001259,  US1537001265, US1324000046, US1443000180, US1613001985, US1617002038, US1619002059, US1619002079, US1619002081, US1517000666, US1517000669, US1517000685, US1407000059, US1441000164, US1443000181, US1443000195, US1441000163,  US1502000477, US1529001080, US1224000020, US1231000023,  US1231000035, US1231000064, US1231000081, US1231000083,  US1234000001, US1234000004, US1234000006, US1234000055,  US1352000017, US1352000023, US1352000024, US1304000041, US1352000059, US1107010009, US1107010013, US1107010014, US1108010043, US1108010057, US1109010073, US1352000062, US1407000038, US1407000041, US1408000002, US1716000343,  US1716000344, US1716000345, US1720000353, US1720000354,  US1720000363, US1709000268, US1525000986, US1525000991,  US1529000995, US1529001027, US1529001033, US1529001068,  US1107010034, US1109010069, US1201010136, US1505000478,  US1505000511, US1505000513, US1505000546, US1343000092,  US1417000006, US1443000219, US1638002490, US1611001828,  US1611001832, US1611001848, US1611001863, US1505000508,  US1505000528, US1505000529, US1505000540, US1534001217,  US1720000386, US1720000407, US1720000409, US1720000416,  US1720000419, US1720000422, US1720000427, US1720000428, US1446000242, US1244000010, US1251000075, US1224000034, US1244000048, US1608001665, US1609001701, US1609001702, US1609001703, US1609001704, US1609001706, US1609001707,  US1609001708, US1609001709, US1609001712, US1609001714,  US1609001722, US1609001727, US1609001729, US1652000009,  US1652000025, US1652000037, US1652000045, US1652000052, US1652000062, US1652000064, US1652000066, US1248000057, US1331000025, US1331000053, US1331000063, US1331000050,  US1331000069, US1331000070, US1334000001, US1331000001, US1331000002, US1331000003, US1331000012, US1331000022, US1238000001, US1202010150, US1304000045, US1325000027, US1328000007, US1328000008, US1334000025, US1343000049, US1331000007, US1446000243, US1446000287, US1450000325 US1431000040, US1433000064, US1433000067, US1537001311, US1537001331, US1547001372, US1550001454, US1550001472, US1550001476, US1550001484, US1407000012, US1244000068, US1248000007, US1248000010, US1248000015, US1248000024, US1248000030, US1251000023, US1239000014, US1203010353, US1202010152, US1202010198, US1202010212, US1202010235, US1203010374, US1203010395, US1202010180, US1202010181,  US1202010184, US1202010185, US1202010187, US1202010190, US1202010192, US1202010195, US1107010004, US1248000031,  US1248000042, US1248000046, US1248000050, US1248000059,  US1502000401, US1502000409, US1502000427, US1502000431,  US1502000433, US1502000435, US1502000437, US1502000447,  US1502000449, US1502000452, US1438000148, US1505000480,  US1343000022, US1107010035, US1109010082, US1109010087,  US1109010091, US1109010100, US1505000499, US1505000541,  US1505000542, US1443000235, US1446000245

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Recalling Firm/
Manufacturer		 Invivo Corporation
12151 Research Pkwy Ste 200
Orlando FL 32826-3286
For Additional Information Contact Philips representative
800-669-1328 Ext. 2
Manufacturer Reason
for Recall		 While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window.
FDA Determined
Cause 2		 Software design
Action The firm, Philips Healthcare, sent an "URGENT - Medical Device Correction" letter dated November 2017 and Field Safety Notice to each known affected customer. The letter describes the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The customers were instructed to do the following: Follow the Action to be Taken by Customer/User section of the Field Safety Notice as follows: -You may continue to use the device provided that each monitored patient in the Pre or Post-Op Holding Area is closely observed by a qualified health care professional and is not left unattended, as specified in the devices instructions for use. The most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. Also, users should always immediately respond to all audible alarms given by the device. Until your device can be corrected, please inform users of the content of this notice and instruct them that to properly exit Full Disclosure playback, use the X icon in the upper right corner of the Full Disclosure Playback control window and do not use the ESC key function. A Philips representative will contact you regarding any affected PCC modules. Each affected PCC will require a software update by Philips. Additionally, all Software and Documentation Media Kits will be replaced. This corrective action will be implemented free of charge by Philips. If you need any further information or support concerning this problem, please contact your local Philips representative: 800-669-1328 option 2, then option 3.
Quantity in Commerce 1,040 units (USA) and 7 units (Foreign)
Distribution Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, NV, OH, PA, RI, SC, TN, TX, VA, WA, and WI ; and countries of: Canada, China, Great Britain and Korea.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MWI and Original Applicant = WITT BIOMEDICAL CORP
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